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Feb. 23 — The chairman of the Senate Finance Committee said Feb. 23 that he hopes to move a bill to clamp down on abuse of pain drugs in the Medicare Part D program.

Sen. Orrin G. Hatch (R-Utah)
said at a panel hearing he hopes to soon move a bill (S. 1913) that would limit some Medicare Part D patients to one physician and one pharmacy for opioid pain medications.

The Stopping Medication Abuse and Protecting Seniors Act would allow Part D plans to implement patient review and restriction (PRR) programs, also known as “lock-in”
programs, to identify beneficiaries with histories of drug abuse and lock them into one prescriber and one pharmacy to help manage potential addiction.

PRR programs are used by Medicaid, but current law doesn't permit their use in Part D plans. The bill was introduced in July 2015 by Sen. Pat Toomey (R-Pa.), and it has been referred to the Senate Finance Committee for consideration.

Another Bill to Fight Epidemic

The bill “would provide Medicare with an important tool in the fight against opioid abuse. Having opioids prescribed by one physician instead of multiple doctors will result in better patient care and reduced abuse,” Hatch said. “It will also make it more likely that a beneficiary with a problem gets the help they need.”
The committee held the hearing to examine the national opioid abuse epidemic.

Sen. Charles E. Schumer
(D-N.Y.) said at the hearing that another “good” bill that addresses the epidemic is the Comprehensive Addiction and Recovery Act (CARA) of 2016 (S. 524). The bill, which was approved by the Senate Judiciary Committee on Feb. 11 , would authorize the attorney general to award grants to address the national opioid abuse and heroin use epidemics.

For the second time, Schumer said he will push for emergency funding legislation (S. 2423)
to be passed as part of the CARA bill when it reaches the Senate floor. The legislation would provide supplemental appropriations totaling $600 million to programs at the Department of Justice and the Department of Health and Human Services to combat the opioid abuse crisis.

At-Risk Beneficiaries

In addition to establishing PRR programs for Part D, the Stopping Medication Abuse and Protecting Seniors Act would:

require Part D to honor beneficiary preferences for their pharmacy and provider unless it is determined that using those providers would contribute to continued drug abuse;

require Part D to notify an at-risk beneficiary of their new status, and conduct a clinical review to ensure seniors who need high amounts of pain pills aren't inappropriately included in program;

direct the HHS to establish clinical criteria for determining who is an at-risk beneficiary based on use of “frequently abused” opioids;

exempt from PRR programs beneficiaries receiving hospice care and those receiving care at a nursing home via a long-term care pharmacy;

allow for data sharing among the Centers for Medicare & Medicaid Services, plans and contractors to address waste, fraud and abuse;

direct the Government Accountability Office to study concerns of prescription drug abuse beyond opioids within Medicare; and

set up procedures to terminate an individual's inclusion in lock-in and protect a beneficiary's appeal rights.

Allan Coukell, senior director of health programs at the Pew Charitable Trusts, expressed support for the Medicare opioid bill, saying in his written testimony that it “achieves an appropriate balance in allowing identification of doctor shopping and at-risk patients, and providing access to effective pain management.”
The Pew Charitable Trusts is an independent nonprofit research and policy organization.

Opioid Marketing

David Hart, assistant attorney-in-charge of the health fraud unit at the Oregon Department of Justice, said opioid marketing and promotion by drug companies also has an effect on the opioid abuse epidemic. He said his department monitors opioid marketing to ensure that unlawful drug promotion doesn't further contribute to the epidemic.

As one example, Hart said his department investigated Insys Therapeutics Inc. over promotions of Subsys (fentanyl) sublingual spray. “Our comprehensive investigation revealed several patterns of alleged misconduct, including reports that the company provided improper financial incentives to doctors to increase prescriptions, aggressively promoted Subsys to doctors not qualified to prescribe the drug, and deceptively promoted Subsys for treatment of mild pain,” he said.

Insys agreed to pay $1.1 million to the state to avoid a lawsuit, which is being used to fund efforts to address the opioid abuse epidemic, Hart said. These efforts include addiction treatment training to increase the number of Oregon physicians in under-served communities and supporting addiction treatment telemedicine consultation services, he said.

Petition to FDA

Meanwhile, on Feb. 22, more than 40 state health officials sent a petition to the Food and Drug Administration, asking the agency to add a black box warning to the labels of benzodiazepine and opioid drugs warning about using the medications together. Benzodiazepines are a class of drugs primarily used for treating anxiety.

A black box warning is the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of an association of a serious hazard with the drug.

“Concurrent misuse of benzodiazepines and opioids is contributing to the epidemic of fatal overdose in the United States,” the petition said. “Biological data indicate that these two drug classes have synergistic effects in producing sedation and respiratory depression. Epidemiological data show polysubstance overdose fatalities involving both opioids and benzodiazepines are common and increasing.”

The petition also asked the FDA to require medication guides for both classes of medications to warn patients of the potential dangers of the combined use of opioids and benzodiazepines.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

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